1. Field of the Invention
The present invention relates to the field of diagnosis/determination of chlamydial infection and disease as well as diagnosis/determination of tubal factor infertility.
2. Background Art
Twenty-five to 35% of patients presenting for infertility evaluation have tubal disease (1-4). Chlamydia trachomatis is the primary sexually transmitted infection responsible for tubal factor infertility (TFI) (5-7) with C. trachomatis antibodies in approximately 70% of human patients (8). C. trachomatis infected cells produce inflammatory cytokines (9-10) which may contribute to upper genital tract inflammatory damage (11-13). Lunefeld et al. found that among patients undergoing in vitro fertilization, those with C. trachomatis antibodies had decreased pregnancy rates (14).
C. trachomatis infection is often asymptomatic so patient history cannot dictate the presence of tubal disease (15-16). Elevated titers of anti-C. trachomatis antibodies are associated with TFI, but detection of overall antibody levels lacks the sensitivity and specificity required for differential diagnosis (17).
The present invention provides chlamydial antigens that can be used to develop rapid and convenient means for diagnosing/determining tubal factor infertility, as well as chlamydial antigens that can be used to develop rapid and convenient means for diagnosing/determining acute chlamydial invention.